The present invention relates generally to composition and method for the preventative treatment of the initiation and progression of bacterially-induced, dental disease including periodontal disease and apparatus for dispensing said composition. The composition includes an active ingredient selected from the group consisting of ascorbic acid and pyrodoxine hydrochloride admitted in a vehicle which includes a gelling agent. The method involves delivery of the composition, in gel form, to a point between the patient's gum and teeth where it may effectively come in contact with the types of bacteria which typically becomes entrapped and cause disease beneath the gum line. Apparatus is provided for dispensing the composition directly to the disease site beneath the gum line.
A tooth, which is composed of a crown and root, is supported or otherwise anchored in the mouth by fibers which connect the root to the jawbone. The crown, which is enamel and visible, provides the chewing or masticating surface while the root, which is embedded in the jawbone, is covered by gum tissue which surrounds the neck of the crown. Periodontal disease, i.e., pyorrhea, is primarily caused by oxygen-sensitive, nutritionally fastidious, subgingival microorganisms, i.e., bacteria which accumulate on the crowns of the teeth beneath the gum line and between the crown and the gum. Bacteria which accumulate beneath the gum line are generally inaccessible to ordinary prophylactic devices such as tooth brushes, floss and mouth wash. Removal of these bacteria is normally accomplished by physical disruption of the bacterial mass by a dentist or hygienist during regularly scheduled scaling and cleaning sessions.
As periodontal disease progresses, the separation between the crown and the gum becomes wider and deeper and bacterial elimination or cleaning with ordinary prophylactic devices becomes even more problematic. Since periodontal disease is usually chronic and progressive in nature, it is advantageous to control or prevent its development.
It is widely acknowledged that periodontal disease is the principal cause of tooth loss. Cost of dental care has escalated dramatically in recent years and is expected to increase even more in the future due to an expanded patient pool resulting from an increase in life expectancy and an increased awareness of the need for treatment.
Although a number of gel products have recently been introduced on the market to clean teeth and gums and to kill bacteria on the surface thereof, such products have generally proven ineffective in penetrating to the interstices which exist between the gum and teeth in order to attack the bacteria where they exist. This inability is, in part, due to the manner in which such products are applied, i.e., to the gum or tooth surface rather than to the spaces between the gum and teeth. Additionally, their inability to effectively prevent periodontal disease is caused by the lack of potency of the compositions themselves.
Many of the prior art compositions for the preventive treatment of periodontal disease include a fluoride in one form or the other. For example, U.S. Pat. No. 4,267,167, which issued on May 12, 1981 to Stewart Weitzman et al., teaches a thixotropic acid-related phosphate fluoride composition; U.S. Pat. No. 4,272,513, which issued on June 9, 1981 to Abdul Gaffar, teaches an oral composition including a fluorine-containing anticaries agent; U.S. Pat. No. 3,666,855, which issued on May 30, 1972 to Joseph C. Muhler, teaches an oral composition including ammonium salts of condensation products of ammonia and phosphorous pentoxide; and U.S. Pat. No. 3,337,412, which issued on Aug. 22, 1967 to Charles H. Elbreder, teaches a therapeutic composition useful for topical application to teeth and which includes a water-soluble, fluoride composition, an acid phosphate composition and a gelling agent.
Examples of different types of dispensing apparatus are shown, for example, in U.S. Pat. No. 4,175,326, which issued on Nov. 27, 1979 to J. M. Goodson and which teaches a hollow fiber device for delivery of therapeutic agents; U.S. Pat. No. 4,276,880, which issued on July 7, 1981 to O. Malmin, and which teaches a cannula for attachment to a dental instrument; U.S. Pat. No. 3,141,583, which issued on July 21, 1964 to W. S. Mapel et al., and which teaches a dispensing device for extrusion injection of viscous composition for veterinary purposes; U.S. Pat. No. 3,790,048, which issued to R. A. Luciano on Feb. 5, 1974, and which teaches an incremental dose dispenser; U.S. Pat. No. 3,504,673, which issued on Apr. 7, 1970 to F. Parisi, and which teaches an injection device with a dosage selector; and U.S. Pat. No. 1,586,302 which issued on May 25, 1926 to L. L. Funk, which teaches a flexible tooth cleaner and medicine carrier.
Recent studies with vitamins and, in particular, vitamin C (ascorbic acid) and vitamin B6 (pyridoxine) have suggested their anti-bacterial effectiveness. Such vitamin compositions have not, heretofore, been used in oral compositions.
Against the foregoing background, it is an object of the present invention to provide a composition for the preventive treatment of dental disease, said composition including one or more active bacterial growth inhibiting ingredients.
It is another object of the present invention to provide such a composition which further includes a gelling agent to permit the resultant composition to be delivered and retained below the gum line for effective preventative treatment of dental disease.
It is still another object of the present invention to provide a method for delivering such composition below the gum line for effective preventative treatment of dental disease.